Published online Jan 14, 2017. doi: 10.3748/wjg.v23.i2.197
Peer-review started: August 31, 2016
First decision: September 21, 2016
Revised: October 1, 2016
Accepted: December 21, 2016
Article in press: December 21, 2016
Published online: January 14, 2017
Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined “boundaries of tolerance”: differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.
Core tip: Some differences between biosimilars and original biologic drugs exist but they are acceptable if they fall within defined “boundaries of tolerance”: variations in some features of the two molecules are considered important only if clinical relevant. Several real-life clinical data are already available in inflammatory bowel disease patients treated with biosimilars with satisfactory outcomes, but further controlled trials are awaited.